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510(k) K930005

DRITRAINER by Laborie Medical Technologies, Ltd. — Product Code KPN

K930005 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Ltd. for the device "DRITRAINER". The FDA issued a decision of Substantially Equivalent on March 3, 1993. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Laborie Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1993
Date Received
January 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type

Other clearances by Laborie Medical Technologies, Ltd.

  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • K240007 — Solar Compact (G4-1) (May 6, 2024)
  • K234107 — Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (April 23, 2024)
  • K090830 — LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (July 21, 2009)
  • K082614 — EVOX ELECTRO DIAGNOSTIC DEVICE (March 6, 2009)
  • K081781 — NUWAV (July 9, 2008)
  • K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (March 5, 2008)
  • K070331 — UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (May 4, 2007)
  • K962009 — UROSTYM (May 20, 1997)
  • K955856 — TEX-AID BLUE (February 16, 1996)

Other clearances for product code KPN

  • K130951 — SIM (August 22, 2013)
  • K971442 — HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,M (January 8, 1998)
  • K971855 — POTTY PAL AND FOREVER-DRY (August 18, 1997)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)
  • K962416 — DRYTIME FOR BLADDER CONTROL SILENT (July 22, 1996)
  • K955338 — DRYTIME FOR POTTY TRAINING (March 12, 1996)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K943558 — PRO'TECT (May 24, 1995)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)

FDA data resources